just checking the European Commission page on diagnostic devices and found that our page was updated on 8/7/2021. can't see the reason for the update, still says specimen nasopharyngeal swab. checked other tests and the 10 or so I checked, none were updated on the same day?
I did notice that under format we had manual, near POC/POC. a lot of other tests only had near POC/POC.
maybe clutching at straws, probably am, but could the manual be the update on our saliva submission seeing that " CE regulatory submission will be made to amend the instruction for use (IFU) of the current EuGeni SARS-CoV-@ ART to include oral saliva sampling."
anyway will be watching for an ann tomorrow. if I am off track, I have never seen this posted before...
COVID-19 In Vitro Diagnostic Medical Device - detail
SARS-CoV-2 Ag RDT
Manufactured by AnteoTech Ltd, Australia - https://www.anteotech.com
Device identification number
2376
CE Marking ✓Yes
HSC common list. ×No
HSC mutual recognition ×No
Format Manual, Near POC / POC
Physical Support. Cassette, Lateral flow
Target. Antigen
Specimen. Nasopharyngeal swab
Pathogens detected. SARS-CoV
Commercial Status. Commercialised
Last Update. 2021-07-08 10:52:02 CET
Comments
The SARS-CoV-2 Ag RDT is a test based on lateral flow technology. The test strips are housed in a cassette for compatibility with the EuGeni fluorescent strip reader. The LoD of the test is 2.8x10^5 genome copies/mL. The SARS-CoV-2 Ag RDT is intended to be used by healthcare professionals for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasopharyngeal specimens collected from individuals who are suspected of COVID-19 infection.
https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/2376
- Forums
- ASX - By Stock
- ADO
- Ann: Test Platform and COVID-19 Test receive CE Mark approval
Ann: Test Platform and COVID-19 Test receive CE Mark approval, page-924
-
-
- There are more pages in this discussion • 36 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add ADO (ASX) to my watchlist
(20min delay)
|
|||||
Last
2.1¢ |
Change
0.000(0.00%) |
Mkt cap ! $52.28M |
Open | High | Low | Value | Volume |
2.1¢ | 2.2¢ | 2.0¢ | $8.929K | 434.2K |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
11 | 1930254 | 2.0¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
2.1¢ | 273617 | 4 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
11 | 1930254 | 0.020 |
9 | 1777381 | 0.019 |
3 | 310168 | 0.018 |
2 | 64748 | 0.017 |
1 | 420000 | 0.016 |
Price($) | Vol. | No. |
---|---|---|
0.021 | 273617 | 4 |
0.022 | 706616 | 3 |
0.023 | 322844 | 5 |
0.024 | 991966 | 4 |
0.025 | 1166439 | 12 |
Last trade - 12.51pm 27/09/2024 (20 minute delay) ? |
Featured News
ADO (ASX) Chart |